Department of Health and Human Services June 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Application for FDA Approval to Market a New Drug'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice is to inform interested parties of clarifications made to the Discretionary Funds for Projects to Establish Individual Development Account (IDA) Programs for Refugees published on Monday, June 6, 2005. The following clarifications should be noted: Section IV.3 stated the following: ``3. Submission Dates and Times Due Date for Applications: August 5, 2005.'' The language in section IV.3 is replaced with: ``3. Submission Dates and Times Due Date for Applications: July 21, 2005.'' Executive Summary: A footnote was omitted in relation to the word ``refugee''. The omitted footnote in the Executive Summary should state: Refugee [1] [1] Eligibility for refugee social services includes: (1) Refugees; (2) asylees; (3) Cuban and Haitian entrants under section 501 of the Refugee Education Assistance Act of 1980 (Pub. L. 96-422); (4) certain Amerasians from Vietnam who are admitted to the U.S. as immigrants under section 584 of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, as included in the FY 1988 Continuing Resolution (Pub. L. 100-202); (5) certain Amerasians from Vietnam who are U.S. citizens under Title II of the Foreign Operations, Export Financing, and Related Programs Appropriations Act of 1989 (Pub. L. 100-461), 1990 (Pub. L. 101-167), and 1991 (Pub. L. 101-513); and (6) victims of a severe form of trafficking who receive certification or eligibility letters from ORR (see 45 CFR 400.43 and ORR State Letters Number 01-13 as modified by Number 02-01 and Number 04-12 on trafficking victims). For convenience, the term ``refugee'' is used in this notice to encompass all such eligible persons. Additional information on eligibility is available at: https://www.acf.hhs.gov/ programs /orr/policy/sl01-13.htm and https://www.acf.hhs.gov/programs / orr/policy/sl02-01.htm.

The Food and Drug Administration (FDA) is confirming the effective date of July 13, 2005, for the direct final rule that appeared in the Federal Register of February 28, 2005 (70 FR 9516). The direct final rule revised the medical device reporting regulations into plain language in order to make the regulations easier to understand. This document confirms the effective date of the direct final rule.

The Administration for Children and Families, Administration on Children, Youth and Families, Child Care Bureau (CCB) announces the availability of funds and request for applications for its FY 2005 Early Learning Opportunities Act (ELOA) grants. Funds will be awarded to eligible Local Councils that have been designated as the Local Council for the purposes of applying for an ELOA grant, as evidenced in a letter of designation, signed by an entity of local government, an Indian Tribe, Regional Corporation, or Native Hawaiian entity.

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2005 funding for the following two programs: Technical Assistance and Capacity Development Demonstration Grant Program for HIV/AIDS-Related Services in Minority Communities; and National Umbrella Cooperative Agreement Program. The purpose of this single announcement is to make it easier for organizations such as community-based organizations, minority-serving organizations, faith-based organizations, and tribal governments and organizations, that meet the eligibility criteria for each program, to identify and apply for FY 2005 OMH funding. As eligibility criteria vary for each program under this announcement, a single notice of funding availability may assist potential applicants to better identify the programs for which they can compete and to target proposals to the program(s) most suitable to the issues faced by their population(s). This announcement should also assist eligible applicants to understand the range of issues that may be supported by the programs and encourage collaborations among organizations that provide services to racial and ethnic minorities. Interested applicants should note the Notice is organized in the manner below. Each section contains the information for both programs, thus applicants should read each section for the applicable information. Sections I (Funding Opportunities), II (Award Information), and III (Eligibility Information) contain program specific information for both of the programs included in this notice of funding availability; Sections IV (Application and Submission Information) and V (Application Review Information) contain information that is both program specific and common to both programs: Sections VI (Award Administration Information), VII (Agency Contacts) and VIII (Other Information) contain common information that applies to both programs.

The purposes of this funding announcement are as follows: (1) To develop and implement programs of comprehensive community-based support services for the target population as described in Public Law 100-505, as amended; (2) to evaluate the implementation and outcomes of these comprehensive support services; and (3) to develop these programs as identifiable sites that other States/locales seeking to implement comprehensive support services for this population can look to for guidance, insight, and possible replication.

On February 9, 2005, the Office of Community Services, Administration for Children and Families, U.S. Department of Health and Human Services published an announcement seeking applications for the Assets for Independence Program. The announcement appeared in Volume 70, pages 6879-6888 of the Federal Register. This document announces one additional application due date of July 15, 2005, which is in addition to the three due dates listed in the February 9 standing announcement (March 15, June 15 and November 1). To be considered timely for this additional due date only, applications must be received at the OCS Operations Center by July 15. (For more details, see submission dates and times section below.) This document also announces two informational telephone conference calls concerning the Assets for Independence Program and the process for submitting a grant application. Submission Dates and Times: The new additional closing date for the Assets for Independence Program is July 15, 2005. (This closing date is in addition to three other valid closing datesMarch 15, June 15 and November 1as noted in the current standing announcement.) Applications received after 4:30 p.m. eastern time on the July 15 closing date will be classified as late, and will not be reviewed this cycle. Deadline: Applications shall be considered as meeting an announced deadline if they are received on or before the due date. Applicants are responsible for ensuring applications are mailed or submitted electronically well in advance of the application due date. Applications hand carried by applicants, applicant couriers, other representatives of the applicant, or by overnight/express mail couriers shall be considered as meeting an announced deadline if they are received on or before the deadline date, between the hours of 8 a.m. and 4:30 p.m., eastern time, between Monday and Friday (excluding Federal holidays). ACF cannot accommodate transmission of applications by facsimile. Therefore, applications transmitted to ACF by fax will not be accepted regardless of date or time of submission and time of receipt. Receipt acknowledgement for application packages will not be provided to applicants who submit their package via mail, courier services, or by hand delivery. Applicants will receive an electronic acknowledgement for applications that are submitted via Grants.gov. Late Applications: Applications that do not meet the criteria above are considered late applications. ACF shall notify each late applicant that its application will not be considered in the current competition. Any application received after 4:30 p.m. eastern time on the deadline date will not be considered for competition. Applicants using express/overnight mail services should allow two working days prior to the deadline date for receipt of applications. Applicants are cautioned that express/overnight mail services do not always deliver as agreed. Extension of Deadlines: ACF may extend application deadlines when circumstances such as acts of God (floods, hurricanes, etc.) occur, or when there are widespread disruptions of mail service, or in other rare cases. A determination to extend or waive deadline requirements rests with the Chief Grants Management Officer. Other Submission Requirements: Submission by Mail: An applicant must provide an original application with all attachments, signed by an authorized representative and two copies. The application must be received at the address below by 4:30 p.m. eastern time on or before the closing date. Applications should be mailed to: Administration for Children and Families, Office of Community Services' Operations Center, 1515 Wilson Boulevard, Suite 100, Arlington, VA 22209, Attention: Administration for Children and Families, Office of Community Services, Assets for Independence Program. Hand Delivery: An applicant must provide an original application with all attachments signed by an authorized representative and two copies. The application must be received at the address below by 4:30 p.m. eastern time on or before the closing date. Applications that are hand delivered will be accepted between the hours of 8 a.m. to 4:30 p.m. eastern time, Monday through Friday. Applications should be delivered to: Administration for Children and Families, Office of Community Services' Operations Center, 1515 Wilson Boulevard, Suite 100, Arlington, VA 22209; Attention: Administration for Children and Families, Office of Community Services, Assets for Independence Program. Electronic Submission: https://www.Grants.gov. Please see Section IV.2 Content and Form of Application Submission of the February 9 announcement, for guidelines and requirements when submitting applications electronically. Informational Conference Calls: The Office of Community Services will host two informational telephone conference calls concerning the Assets for Independence Program and the grant application process on June 20 and 21, 2005 at 2 p.m. until approximately 3 p.m. These calls will be open to all interested individuals. Please call the Office of Community Services on (202) 401-4626 or go to the OCS Asset Building Web site at https://www.acf.hhs.gov to register for a call and for dial- in information. Participants are strongly encouraged to register, as the number of lines is limited. OCS plans to make handout materials available to all individuals who register for either of the informational calls. Announcement Availability: The Assets for Independence Program announcement and all application materials are available at https:// www.Grants.gov. Standard forms and certifications may also be found at https://www.acf.hhs.gov/programs/ofs/forms.htm. Finally, the OCS Asset Building Web site at https://www.acf.hhs.gov/assetbuilding provides much information about the Assets for Independence Program and the application process. The page includes links to all required forms as well as to a guidebook for developing an AFI Project and applying for an AFI grant.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including renewal of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.